ECSP034789A - RECONSTITUABLE PARENTERAL COMPOSITION CONTAINING A COX-2 TA INHIBITOR - Google Patents

RECONSTITUABLE PARENTERAL COMPOSITION CONTAINING A COX-2 TA INHIBITOR

Info

Publication number
ECSP034789A
ECSP034789A EC2003004789A ECSP034789A ECSP034789A EC SP034789 A ECSP034789 A EC SP034789A EC 2003004789 A EC2003004789 A EC 2003004789A EC SP034789 A ECSP034789 A EC SP034789A EC SP034789 A ECSP034789 A EC SP034789A
Authority
EC
Ecuador
Prior art keywords
composition
weight
parenterally acceptable
cox
reconstituable
Prior art date
Application number
EC2003004789A
Other languages
Spanish (es)
Inventor
Tugrul Kararli
Aziz Karim
Sandeep Nema
Original Assignee
Pharmacia Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23075770&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP034789(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmacia Corp filed Critical Pharmacia Corp
Publication of ECSP034789A publication Critical patent/ECSP034789A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pyridine Compounds (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
  • Pyrane Compounds (AREA)
  • Furan Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Una composición farmacéutica que comprende, en forma de polvo (a) al menos un agente terapéutico soluble en agua seleccionado de drogas y prodrogas selectivas inhibitorias de COX-2 y sales de las mismas, por ejemplo parecoxib sódico en una cantidad total terapéuticamente efectiva que constituye aproximadamente el 30% hasta aproximadamente 90% por peso; (b) un agente amortiguador parenteralmente aceptable en una cantidad de aproximadamente 5% hasta aproximadamente 60% por peso, y opcionalmente (c) otros ingredientes excipientes parenteralmente aceptables en una cantidad total no mayor a aproximadamente 10% por peso, de la composición. La composición es reconstituible en un líquido disolvente parenteralmente aceptable para formar una solución inyectable, Se suministra un proceso de liofilización para la preparación de tal composición.A pharmaceutical composition comprising, in powder form (a) at least one water-soluble therapeutic agent selected from drugs and selective COX-2 inhibitory prodrugs and salts thereof, for example sodium parecoxib in a therapeutically effective total amount constituting about 30% to about 90% by weight; (b) a parenterally acceptable buffering agent in an amount of about 5% to about 60% by weight, and optionally (c) other parenterally acceptable excipient ingredients in a total amount not greater than about 10% by weight, of the composition. The composition is reconstitutable in a parenterally acceptable solvent liquid to form an injectable solution. A lyophilization process is provided for the preparation of such a composition.

EC2003004789A 2001-04-03 2003-10-03 RECONSTITUABLE PARENTERAL COMPOSITION CONTAINING A COX-2 TA INHIBITOR ECSP034789A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US28105801P 2001-04-03 2001-04-03

Publications (1)

Publication Number Publication Date
ECSP034789A true ECSP034789A (en) 2004-07-23

Family

ID=23075770

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2003004789A ECSP034789A (en) 2001-04-03 2003-10-03 RECONSTITUABLE PARENTERAL COMPOSITION CONTAINING A COX-2 TA INHIBITOR

Country Status (46)

Country Link
US (1) US7695736B2 (en)
EP (1) EP1372645B1 (en)
JP (1) JP4511792B2 (en)
KR (1) KR100980685B1 (en)
CN (3) CN107213121A (en)
AP (1) AP1776A (en)
AR (1) AR033688A1 (en)
AT (1) ATE310516T1 (en)
AU (1) AU2002256031B2 (en)
BG (1) BG66367B1 (en)
BR (1) BRPI0208652B8 (en)
CA (1) CA2442906C (en)
CZ (1) CZ299623B6 (en)
DE (1) DE60207535T2 (en)
DK (1) DK1372645T3 (en)
EA (1) EA006554B1 (en)
EC (1) ECSP034789A (en)
EG (1) EG24345A (en)
ES (1) ES2252448T3 (en)
GE (1) GEP20063775B (en)
GT (1) GT200200065A (en)
HK (2) HK1243338A1 (en)
HR (1) HRP20030793B1 (en)
HU (1) HU229264B1 (en)
IL (2) IL158209A0 (en)
IS (1) IS2408B (en)
JO (1) JO2337B1 (en)
MA (1) MA27008A1 (en)
ME (1) MEP56908A (en)
MX (1) MXPA03009013A (en)
MY (1) MY137736A (en)
NO (1) NO333381B1 (en)
NZ (1) NZ528547A (en)
OA (1) OA12498A (en)
PA (1) PA8542701A1 (en)
PE (1) PE20021017A1 (en)
PL (1) PL205658B1 (en)
RS (1) RS50430B (en)
SI (1) SI1372645T1 (en)
SK (1) SK287754B6 (en)
SV (1) SV2002000969A (en)
TN (2) TNSN02039A1 (en)
TW (1) TWI314867B (en)
UA (1) UA77173C2 (en)
WO (1) WO2002080912A1 (en)
ZA (1) ZA200307630B (en)

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